DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 19-20, and 33-41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 requires the first polymer and the second polymer are polymer compatible; this is unclear because they are polymers; it is unclear what this is requiring. Is this stating the first polymer is compatible with the second polymer (e.g. they mix)? That this is a biopolymer compatible material, or that the polymers are compatible, but not necessarily with the other polymer?
Claim 19, line 5 requires an electrode controller in electrical communication with an electrode in an apparatus; line 13 requires the apparatus comprises a plurality of embedded electrodes; it is unclear if the electrode in line 5 is part of the embedded electrodes or if this is a different electrode?
Dependent claims inherit the same deficiencies.
Claim 33 is unclear because it states responsive to transmitting electrical current with the plurality of electrodes; this is unclear because claim 19 states in lines 5-6 that the transmit of electrical current is performed with “an electrode” and not a plurality of electrodes. Similar to above it is unclear if this electrode is part of the plurality of embedded electrodes or if it is a different structure.
Claim 34 requires activating the plurality of electrodes by contacting one or more sensors; it is unclear what is being contacted by the sensor in order to activate the plurality of electrodes? Does the sensor contact biological tissue or is the sensor contacting the electrodes? Or is the sensor detecting a condition which activates the electrodes?
Claim 35 directs the electrode controller in response to a first symptom; it is unclear how the controller identifies this symptom as there is no step of sensing or inputting a response to the processor.
Claim 36 requires “transmit electrical current to”; it is unclear if this is the same electrical current form claim 19 or if this is additional electrical current.
Claim 37 causes the apparatus to transmit with an electrode controller in electrical communication with an electrode; it is unclear if this is the same electrode controller and electrode of claim 19 or if this is a separate structure.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 19, 33-36, and 38-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder et al (US Publication 2018/0296822) in view of Laghi et al (US Publication 2021/0186719) and Kuntaegowdanahalli et al (US Publication 2014/0277583).
Referring to Claim 19, Schroeder et al teaches a non-transitory computer-readable medium comprising instructions to cause a processor to: store instructions which, when executed by one or more processors of a system, cause the system to: transmit, with an electrode controller in electrical communication with an electrode in an apparatus electrical current through a residual limb of an amputee (e.g. Figure 2, Element 150 and Paragraphs [0037]-[0042]), stimulate nerve fibers in the residual limb responsive to transmitting electrical current with the electrode (e.g. Paragraphs [0041-0042] disclose electrical signals stimulate nerves); wherein the apparatus comprises: a prosthetic liner made of a first material (e.g. Figure 1, Element 110 and Paragraph [0020]); and a substrate made of a second polymer configured to contact the skin of the residual limb and comprising a plurality of embedded electrodes and a conductor (e.g. Figure 1, substrate 120 with electrodes 130 and conductor 140), and wherein the prosthetic liner is bonded to the substrate (e.g. Figure 2). However, Schroeder et al does not explicitly disclose the first material is a polymer which is compatible with the second polymer; and an electrical current with a pulse frequency up to 180 pulses per second and a pulse width of up to 400 microseconds. Laghi et al teaches that it is known to use a prosthetic having a fabric liner comprising polymer (which is compatible with the polymers in Paragraph [0021] of Schroeder) as set forth in Paragraph [0055] to provide improved comfort, durability, and performance. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Schroeder et al, with the first material is a polymer which is compatible with the second polymer as taught by Laghi et al, since such a modification would provide the predictable results of improved comfort, durability, and performance. Kuntaegowdanahalli et al teaches that it is known to use a prosthetic to cause nerve stimulation with a frequency of less than 180 pulses per second and a pulse width of up to 400 microseconds as set forth in Paragraphs [0051], [0053], [0056], and [0057] to provide proprioceptive perception. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Schroeder et al, with an electrical current to the nerve an electrical current with a pulse frequency up to 180 pulses per second and a pulse width of up to 400 microseconds as taught by Kuntaegowdanahalli et al, since such a modification would provide the predictable results of proprioceptive perception.
Referring to Claim 33, Schroeder et al in view of Laghi et al and Kuntaegowdanahalli et al teaches the non-transitory computer-readable medium of claim 19, wherein the instructions are further executable by the processor to: stimulates muscles in the residual limb responsive to transmitting electrical current with the plurality of electrodes (e.g. Paragraph [0042] discloses the electrical signals can be transmitted to muscle).
Referring to Claim 34, Schroeder et al in view of Laghi et al and Kuntaegowdanahalli et al teaches the non-transitory computer-readable medium of claim 19, wherein the instructions are further executable by the processor to: activates the plurality of electrodes by contacting one or more sensors (e.g. Paragraph [0042] discloses the sensor information can be communicated to the compliant electrode as feedback).
Referring to Claim 35, Schroeder et al in view of Laghi et al and Kuntaegowdanahalli et al teaches the non-transitory computer-readable medium of claim 19, wherein the instructions are further executable by the processor to: directs the electrode controller to direct a first positive electrode to transmit electrical current to the residual limb and a negative electrode to receive the electrical current in response to a first symptom (e.g. Paragraph [0039] discloses electrodes 130 have a positive contact and a negative contact and a TENS device necessarily has a positive and negative contact to transmit current).
Referring to Claim 36, Schroeder et al in view of Laghi et al and Kuntaegowdanahalli et al teaches the non-transitory computer-readable medium of claim 19, wherein the instructions are further executable by the processor to: transmits electrical current to treat one or more symptoms of post-operative pain or post- operative sensation (e.g. Paragraph [0042] and Kuntaegowdanahalli et al [0056] and [0057] would provide the predictable results of proprioceptive perception).
Referring to Claim 38, Schroeder et al in view of Laghi et al and Kuntaegowdanahalli et al teaches the non-transitory computer-readable medium of claim 19, wherein the instructions are further executable by the processor to: causes one or more electrodes to transmit electrical current to the residual limb with a secondary controller in wireless communication with the electrode controller (e.g. Paragraph [0040] discloses additional processing can communicate via wireless communication such as BLUETOOTH).
Referring to Claim 39, Schroeder et al in view of Laghi et al and Kuntaegowdanahalli et al teaches the non-transitory computer-readable medium of claim 38, wherein: the secondary controller is a computing device and in wireless communication with the electrode controller (e.g. Paragraph [0040] discloses additional processing can communicate via wireless communication such as BLUETOOTH).
Referring to Claim 40, Schroeder et al in view of Laghi et al and Kuntaegowdanahalli et al teaches the non-transitory computer-readable medium of claim 19, wherein the instructions are further executable by the processor to: controls which electrode in an array of electrodes transmits electrical current through a specific region of the residual limb (e.g. Paragraphs [0037]-[0042]).
Referring to Claim 41, Schroeder et al in view of Laghi et al and Kuntaegowdanahalli et al teaches the non-transitory computer-readable medium of claim 19, wherein the conductor is a plurality of conductive wires (e.g. Figure 2, Element 140 and Paragraph [0031]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder et al (US Publication 2018/0296822) in view of Laghi et al (US Publication 2021/0186719) and Kuntaegowdanahalli et al (US Publication 2014/0277583) as applied to claim 19 above, and further in view of Flaherty et al (US Publication 2006/0167564).
Referring to Claim 20, Schroeder et al in view of Laghi et al and Kuntaegowdanahalli et al teaches the non-transitory computer-readable medium of claim 19, where in the sensor data is obtained (e.g. Paragraph [0042] discloses the sensor information). However, Schroeder et al does not explicitly disclose wherein the instructions are further executable by the processor to: detect physiological parameters with at least one sensor; measure physiological data from the physiological parameters; store the measured physiological data; process the measured physiological data; provide outputs to a user or other computing device responsive to processing the measured physiological data.
Flaherty et al teaches that it is known to use physiological sensors to detect physiological parameters with at least one sensor; measure physiological data from the physiological parameters; store the measured physiological data; process the measured physiological data; provide outputs to a user or other computing device responsive to processing the measured physiological data as set forth in Paragraphs [0048], [0062], and [0124] to provide improved physical therapy by avoiding patient discomfort or potential adverse events and/or in order to optimize the therapy. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Schroeder et al, with physiological sensors to detect physiological parameters with at least one sensor; measure physiological data from the physiological parameters; store the measured physiological data; process the measured physiological data; provide outputs to a user or other computing device responsive to processing the measured physiological data as taught by Flaherty et al, since such a modification would provide the predictable results of improved physical therapy by avoiding patient discomfort or potential adverse events and/or in order to optimize the therapy.
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder et al (US Publication 2018/0296822) in view of Laghi et al (US Publication 2021/0186719) and Kuntaegowdanahalli et al (US Publication 2014/0277583) as applied to claim 19 above, and further in view of Sears et al (US Patent 5,888,213).
Referring to Claim 37, Schroeder et al in view of Laghi et al and Kuntaegowdanahalli et al teaches the non-transitory computer-readable medium of claim 19, wherein the instructions are further executable by the processor to: causes the apparatus to: transmit, with an electrode controller in electrical communication with an electrode in the substrate, electrical current through the residual limb (e.g. Paragraphs [0037]-[0042]); and stimulate nerve fibers in the residual limb responsive to transmitting electrical current with the electrode (e.g. Paragraphs [0037]-[0042]). However, Schroeder et al does not explicitly disclose the electrical current is responsive to input received from the amputee with a user interface. Sears et al teaches that it is known to use a user interface program to provide self-calibration as set forth in Column 4 lines 36-39 to provide improved operations by adjusting the sensitivity and performance of the device. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Schroeder et al, with the electrical current is responsive to input received from the amputee with a user interface as taught by Sears et al, since such a modification would provide the predictable results of improved operations by adjusting the sensitivity and performance of the device.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 19 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,201,536 AND claim 1 of U.S. Patent No. 11,986,402 AND Claim 2 of U.S. Patent No. 11,833,064. Although the claims at issue are not identical, they are not patentably distinct from each other because following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claim 19 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/029,898 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hoffer (US Patent 7,302,296) discloses a prosthetic limb with electrodes for stimulating nerves to alleviate phantom limb pain in an amputee, and/or for providing sensory feedback from a prosthetic limb worn by an amputee.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796
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